FDA recommends steps to improve diversity in clinical trials

The US Food and Drug Administration (FDA) has recommended steps for drugmakers and medical device makers to improve racial, ethnic and other diversity in their clinical trials.

The draft guidance, “Diversity Action Plans to Improve Enrollment of Participants from Underrepresented Populations in Clinical Studies,” includes suggestions for companies and researchers conducting trials on how to set goals for study enrollment, separated by age group, ethnicity, sex and race, and describe how they intend to meet those goals, the FDA said.

The objective of the guidance is to improve the composition of patient population at clinical trials that have had lower participation by some groups including Black Americans despite higher rates of certain diseases in the underrepresented groups than in the general population.

The FDA said the goals for a study, or the “diversity action plan”, should be set keeping in mind the estimated prevalence of a disease for which the drug or device is being evaluated.

“These plans may help ensure that sponsors are thinking critically and intentionally about the many characteristics of the patient population they aim to treat when designing their clinical study,” said Richard Pazdur director of FDA’s Oncology Center of Excellence.

FDA will require companies to file plans on how they intend to increase diversity in studies of most new drugs and medical devices under the 2022 Food and Drug Omnibus Reform Act.